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Clinical utility, safety, and efficacy of pregabalin in the treatment of fibromyalgia

Authors Bhusal S, Diomampo S, Magrey M

Received 1 September 2015

Accepted for publication 18 December 2015

Published 17 February 2016 Volume 2016:8 Pages 13—23

DOI https://doi.org/10.2147/DHPS.S95535

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Boyang Bian

Peer reviewer comments 2

Editor who approved publication: Professor Chul Ahn


Santosh Bhusal,1 Sherilyn Diomampo,1 Marina N Magrey2

1Division of Rheumatology, Metrohealth Medical Center, 2Case Western Reserve University School of Medicine at Metrohealth Medical Center, Cleveland OH, USA

Abstract: Fibromyalgia is a chronic debilitating medical syndrome with limited therapeutic options. Pregabalin, an anticonvulsant and α-2-Δ subunit receptor ligand, is one of the anchor drugs approved by the US Food and Drug Administration for the treatment of fibromyalgia. The drug has shown clinically meaningful benefits across multiple symptom domains of fibromyalgia. Efficacy of pregabalin in fibromyalgia pain has been evaluated in at least five high-quality randomized trials, two long-term extension studies, a meta-analysis, a Cochrane database systematic review, and several post hoc analyses. These studies also hint towards a meaningful benefit on sleep, functioning, quality of life, and work productivity. Side effects of pregabalin, although common, are mild to moderate in intensity. They are noted early during therapy, improve or disappear with dose reduction, and are not usually life- or organ threatening. In most patients, tolerance develops to the most common side effects, dizziness, and somnolence, with time. With close clinical monitoring at initiation or dose titration, pregabalin can be effectively used in primary care setting. Pregabalin is cost saving with long-term use and its cost-effectiveness profile is comparable, if not better, to that of other drugs used in fibromyalgia. In the present era of limited therapeutic options, pregabalin undoubtedly retains its role as one of cardinal drugs used in the treatment of fibromyalgia. This review intends to discuss the clinical utility of pregabalin in the management of fibromyalgia with a focus on efficacy, safety, and cost-effectiveness.

Keywords: fibrositis, myofascial pain, diffuse pain syndrome, lyrica

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